Phase 2 Randomized Study to Compare Ultrasonic Drug Delivery to Standard of Care for the Treatment of Infections in Non-Healing Wounds

Exclusion Criteria

• •Patients with conditions that would alter the interpretation of a primary endpoint, including: patients with neutropenia; and/or patients with peripheral neuropathy
• •Participation in another study of an investigational drug or device within 30 days prior to administration of investigational treatment.
• •Pregnant or lactating women.
• •Patients with a known allergic reaction or hypersensitivity to cefazolin or penicillin.
• •Infections caused exclusively by gram-negative bacteria (without gram-positive bacteria present) and infections caused by fungi, whether alone or in combination with a bacterial pathogen.
• •Presence of gram-negative bacteremia, even in the presence of gram-positive infection or gram-positive bacteremia.
• •Patients with evidence of meningitis, gas gangrene, gangrene, septic arthritis, or osteomyelitis, endovascular infection, such as clinical and/or echocardiographic evidence of endocarditis or septic thrombophlebitis.
• •Infections involving a diabetic foot ulceration, perirectal abscess or a decubitus ulcer.
• •Patients with an infection involving a limb with evidence of critical ischemia of an affected limb defined as any of the following criteria: absent or abnormal Doppler wave forms, toe blood pressure of \<45 mm Hg, ankle brachial index \<0.4, critical ischemia as assessed by a vascular surgeon.
• •Patient with an infected device.
• •Suspicion of skin cancer at the wound site (i.e., clinical evaluation is currently on-going).
• •Patients who have a history of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association (NYHA) functional classification of III (marked limitation of physical activity comfortable at rest but less than ordinary activity results in fatigue, palpitation or dyspnoea) or Class IV (unable to carry out any physical activity without discomfort - symptoms at rest. If any physical activity is undertaken, discomfort is increased).
• •Patients who have any other life-threatening illness or organ system dysfunction, which, in the opinion of the Investigator, would either compromise patient safety or interfere with the evaluation of the safety of the test drug.
• •Anticipated need of antibiotic therapy for longer than 14 days.
• •Medical conditions in which chronic inflammation may preclude assessment of clinical response to therapy even after successful treatment (e.g., chronic stasis dermatitis of the lower extremity).
• •Known or suspected human immunodeficiency virus (HIV) infected patients with a CD4 (cluster of differentiation 4) cell count \< 200 cells/mm3 or with a past or current acquired immunodeficiency syndrome (AIDS) - defining condition and unknown CD4 count.
• •Patients with a recent bone marrow transplant.
• •Patients receiving oral steroids \> 20 mg prednisone per day (or equivalent) or receiving immunosuppressant drugs after organ transplantation.
• •Patients with a rapidly fatal illness who are not expected to survive for three months.
• •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.